A pair of Israeli health tech companies, Beyond Verbal and Healthymize, plan to merge to form Newton, Mass.-based Vocalis Health. The company will be focused on developing vocal biomarkers, which track voice patterns via phone calls or smart devices to screen for various voice-indicating ailments including chronic respiratory and cardiac conditions, as well as depression. Vocalis has raised a $9 million financing led by Israeli health tech and life science venture firm Amoon to accumulate additional clinical data and enhance its voice database.

TORONTO – Synaptive Medical Inc. has completed the first round of a new preferred equity investment totaling $25 million led by Guelph-Ontario-based Linamar Corp., which also entered into a manufacturing agreement with Synaptive, and Calgary’s Audible Capital Corp.

As part of newly announced collaborations with Cleveland-based Viewray Inc., Elekta AB assumed a 9.9% stake in the company, and Medtronic plc also made a minority investment. The company's largest shareholder, Fosun International Ltd., also led the round. "In total, the company raised approximately $139 million, net of fees," Viewray President and CEO Scott Drake told BioWorld MedTech.

Menlo Park, Calif.-based Akoya Biosciences Inc. has scooped up $50 million in financing, with an eye toward growing via the expansion of commercial and operational resources and continuing product development activities around its platforms for spatial biology.

Toronto-based Moleculight Inc. has received U.S. FDA 510(k) clearance for its i:X hand-held fluorescence imaging device for use in detecting bacteria in wounds at the point of care. The milestone comes a little over a year after the agency granted de novo clearance for the device in August 2018 and lends additional credence to the device’s benefits in wound evaluation and management. “The granting of our 510(k) clearance by the FDA for the i:X hand-held fluorescence imaging device is very exciting and is a further validation of the growing clinical evidence supporting the utility of our imaging platform,” said Anil Amlani, Moleculight’s CEO.

The U.S. FDA has granted investigational device exemption approval for the use of Personal Genome Diagnostics Inc.’s (PGDx) elio tissue complete assay in a Merck & Co. Inc. trial of a Keytruda (pembrolizumab)-based combination therapy. Specifically, the assay will be used during the trial to analyze genomic markers to direct patient enrollment and stratification.

The U.S. FDA has granted investigational device exemption approval for the use of Personal Genome Diagnostics Inc.’s (PGDx) elio tissue complete assay in a Merck & Co. Inc. trial of a Keytruda (pembrolizumab)-based combination therapy.

Genomic testing firm Veracyte Inc., of South San Francisco, has inked a definitive agreement with Seattle-based Nanostring Technologies Inc. for the global rights to Nanostring’s Ncounter platform. The deal – for $50 million in cash and Veracyte stock, plus up to $10 million in potential milestone payments – will allow Veracyte to develop and commercialize diagnostic tests on Nanostring’s Ncounter Flex system.